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DAY ONE Tuesday, June 19, 2018

12:00

Main Conference Registration

1:15

Chairman’s Welcome and Opening Remarks

Alex Patterson
Senior Medical Director, Medical Device Safety Head
Abbott

1:30

REMOTE PRESENTATION Uncover the Recipe for Successful Post-Market Safety Reporting for Combination Products

Khaudeja Bano, MD
Head of Medical Affairs
Abbott Molecular

2:30

Sharing Vyaire Medical’s Journey to Improve Efficiency from a Data Perspective-Post Market Surveillance

Chris Silvers
Vice President of Quality Assurance & Compliance
Vyaire Medical

3:15

Networking and Refreshment Break

3:45

Hot Topic Review Panel

Alex Patterson
Director, Post Market Quality
ResMed

Ron Makar CBA, CHA, CQA, CQE, CMQ-OE (ASQ)
Owner & Principal Consultant
Innovative Quality Consulting, LLC

Sharon Perez
Director, Global Medical Safety
Novocure

4:30

Strategies for Utilizing Statistical Information to Set Complaint Thresholds

Sonny Nguyen
Director, QA/RA
PeriGen, Inc

5:15

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Wednesday, June 20, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Alex Patterson
Director, Post Market Quality
ResMed

8:45

Assess FDA Inspection Process for Product Complaints

Lawrence S. Perruzza, MSc, RAC
Director, Case Investigation & Resolution
Roche Molecular Diagnostics

9:30

Evaluate Best Practices for Managing Risks While Dealing with Product Complaints

I. Introduction to Risk Management

II. Framework for Managing Risk

III. Risk Control

IV. Interactive Exercise

Vaishali Shukla, MSC, MS, MS
Head of Clinical QA and Product Quality Management
uniQure

11:00

Networking and Refreshment Break

11:30

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (1-2)

Session 1: Create a Superior Customer Experience While Managing Product Complaints

I. Managing the Product Complaint Intake Processes

II. Responding to Customers Regarding their Product Complaint

III. Product Complaint Prevention

Susan Busse
Advisor, Global Product Complaints
Eli Lilly & Company

Session 2: ISO 13485:2016 — Preparing for the International Medical Device QMS Standard

I. Examining the Critical Changes of This Standard

II. Post-Market Surveillance

III. Interactive Exercise

Ron Makar, CBA, CHA, CQA, CQE, CMQ-OE (ASQ)
Owner & Principal Consultant
Innovative Quality Consulting, LLC

1:00

Networking Luncheon

2:00

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (3-4)

Session 3: Single patient INDs and the New Right to Try Law

I. What are the impacts of data collection on safety?

II. Understand how to compile / submit a Single Patient IND

III. Assess the IND review process and procedures

IV. Review IND sponsor-investigator responsibilities

V. • Discuss the new Right to Try Law

T. Che Jarrell, BSPH, MPIA, RAC
Proprietor and Principal Consultant
Milestone Regulatory Experts, LLC

Session 4:Best Practices for Complying with the EU Medical Device Regulation

3:30

Networking and Refreshment Break

4:00

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (5-6)

Session 5: Assess How to Create Complaint Trending Systems for Drug and Device Products

I. Survey FDA’s FAERS System —
Leverage evaluation principles and recognize limitations

II. Deconstruct the Product Complaint/Adverse Event Report

III. Develop an Algorithm/Feedback Loop-Based System that Accurately Measures Product/Performance Outcomes

IV. Scenarios/Interactive Activity

T. Che Jarrell, BSPH, MPIA, RAC
Proprietor and Principal Consultant
Milestone Regulatory Experts, LLC

Session 6:Best Practices in Device Complaint Investigation, Documentation, and MDR Reporting

I. Best practices in obtaining event and product information: what, when, and how.

II.Discover the importance of appropriate complaint documentation and how to avoid common pitfalls.

III. Review common mistakes in MDR reports and how to combat them.

IV. Learn about complaint file review methods to prevent missed MDR reporting.

V. Evaluate complaint and MDR tracking methods to ensure timely MDR submissions.

Geoffrey Gannon
Product Surveillance Manager
Zimmer Biomet

5:30

Close of Day Two

DAY THREE Thursday, June 21, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day Two

Alex Patterson
Director, Post Market Quality
ResMed

8:45 - 12:15

IN-CONFERENCE 3-HOUR WORKSHOP

Evaluate How Connected Devices Impacts
Your Complaints Handling Process

PRESENTATION 1: Creating a Robust Complaint System on High-Volume, End-User Products

PRESENTATION 2: Look at the Similarities and Differences Between Complaint Handling of Traditional vs Connected Devices

ROUNDTABLE DISCUSSION 1: Mobile Phones, Wearables and Connected Devices —
Evaluate Digital Health Impact on the Complaint Handling Process

ROUNDTABLE DISCUSSION 2: Software as Medical Devices —
How Do We Evaluate Alleged Deficiencies in Software Products Like Apps?

Interactive Exercise

Workshop Leaders:

Rikke Lewinsky
Specialist, Post market surveillance
Novo Nordisk A/S

Alex Patterson
Director, Post Market Quality
ResMed

12:15

Networking Luncheon

1:00

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (7-8)

Session 7: Explore the Impact of Social Media on the Pharmaceutical and Medical Device Industries

I. Guidelines and Enforcement Activities Involving Social Media

II. Social Media Activity in the Pharmaceutical and Medical Device Industries

III. Interactive Exercise

Sharon Perez
Director, Global Medical Safety
Novocure

Session 8: The Balancing Act Between Regulatory Requirements — Public Interest vs Individual Privacy Rights in the EU MDR vs EU GDPR

Meeting the reporting legal requirements of regulations, such as the EU Medical Device Reporting (MDR), and the recently-mandated EU General Data Protection Regulation (GDPR), can be a daunting task. With seemingly clashing requirements, the balancing act that needs to occur within an organization to achieve compliance to both is a delicate one. Has your organization considered the impact of consistently meeting these two regulations simultaneously? This session familiarizes you with both regulations, with a special focus on the critical consideration for implementing them within your organization.

Kari Miller
Vice President, Regulatory and Product Management
Pilgrim Quality Solutions

2:30

Close of Conference

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DAY ONE Tuesday, June 19, 2018

12:00

Main Conference Registration

1:15

Chairman’s Welcome and Opening Remarks

Alex Patterson
Senior Medical Director, Medical Device Safety Head
Abbott

1:30

REMOTE PRESENTATION Uncover the Recipe for Successful Post-Market Safety Reporting for Combination Products

Khaudeja Bano, MD
Head of Medical Affairs
Abbott Molecular

2:30

Sharing Vyaire Medical’s Journey to Improve Efficiency from a Data Perspective-Post Market Surveillance

Chris Silvers
Vice President of Quality Assurance & Compliance
Vyaire Medical

3:15

Networking and Refreshment Break

3:45

Hot Topic Review Panel

Alex Patterson
Director, Post Market Quality
ResMed

Ron Makar CBA, CHA, CQA, CQE, CMQ-OE (ASQ)
Owner & Principal Consultant
Innovative Quality Consulting, LLC

Sharon Perez
Director, Global Medical Safety
Novocure

4:30

Strategies for Utilizing Statistical Information to Set Complaint Thresholds

Sonny Nguyen
Director, QA/RA
PeriGen, Inc

5:15

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Wednesday, June 20, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Alex Patterson
Director, Post Market Quality
ResMed

8:45

Assess FDA Inspection Process for Product Complaints

Lawrence S. Perruzza, MSc, RAC
Director, Case Investigation & Resolution
Roche Molecular Diagnostics

9:30

Evaluate Best Practices for Managing Risks While Dealing with Product Complaints

I. Introduction to Risk Management

II. Framework for Managing Risk

III. Risk Control

IV. Interactive Exercise

Vaishali Shukla, MSC, MS, MS
Head of Clinical QA and Product Quality Management
uniQure

11:00

Networking and Refreshment Break

11:30

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (1-2)

Session 1: Create a Superior Customer Experience While Managing Product Complaints

I. Managing the Product Complaint Intake Processes

II. Responding to Customers Regarding their Product Complaint

III. Product Complaint Prevention

Susan Busse
Advisor, Global Product Complaints
Eli Lilly & Company

Session 2: ISO 13485:2016 — Preparing for the International Medical Device QMS Standard

I. Examining the Critical Changes of This Standard

II. Post-Market Surveillance

III. Interactive Exercise

Ron Makar, CBA, CHA, CQA, CQE, CMQ-OE (ASQ)
Owner & Principal Consultant
Innovative Quality Consulting, LLC

1:00

Networking Luncheon

2:00

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (3-4)

Session 3: Single patient INDs and the New Right to Try Law

I. What are the impacts of data collection on safety?

II. Understand how to compile / submit a Single Patient IND

III. Assess the IND review process and procedures

IV. Review IND sponsor-investigator responsibilities

V. • Discuss the new Right to Try Law

T. Che Jarrell, BSPH, MPIA, RAC
Proprietor and Principal Consultant
Milestone Regulatory Experts, LLC

Session 4:Best Practices for Complying with the EU Medical Device Regulation

3:30

Networking and Refreshment Break

4:00

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (5-6)

Session 5: Assess How to Create Complaint Trending Systems for Drug and Device Products

I. Survey FDA’s FAERS System —
Leverage evaluation principles and recognize limitations

II. Deconstruct the Product Complaint/Adverse Event Report

III. Develop an Algorithm/Feedback Loop-Based System that Accurately Measures Product/Performance Outcomes

IV. Scenarios/Interactive Activity

T. Che Jarrell, BSPH, MPIA, RAC
Proprietor and Principal Consultant
Milestone Regulatory Experts, LLC

Session 6:Best Practices in Device Complaint Investigation, Documentation, and MDR Reporting

I. Best practices in obtaining event and product information: what, when, and how.

II.Discover the importance of appropriate complaint documentation and how to avoid common pitfalls.

III. Review common mistakes in MDR reports and how to combat them.

IV. Learn about complaint file review methods to prevent missed MDR reporting.

V. Evaluate complaint and MDR tracking methods to ensure timely MDR submissions.

Geoffrey Gannon
Product Surveillance Manager
Zimmer Biomet

5:30

Close of Day Two

DAY THREE Thursday, June 21, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day Two

Alex Patterson
Director, Post Market Quality
ResMed

8:45 - 12:15

IN-CONFERENCE 3-HOUR WORKSHOP

Evaluate How Connected Devices Impacts
Your Complaints Handling Process

PRESENTATION 1: Creating a Robust Complaint System on High-Volume, End-User Products

PRESENTATION 2: Look at the Similarities and Differences Between Complaint Handling of Traditional vs Connected Devices

ROUNDTABLE DISCUSSION 1: Mobile Phones, Wearables and Connected Devices —
Evaluate Digital Health Impact on the Complaint Handling Process

ROUNDTABLE DISCUSSION 2: Software as Medical Devices —
How Do We Evaluate Alleged Deficiencies in Software Products Like Apps?

Interactive Exercise

Workshop Leaders:

Rikke Lewinsky
Specialist, Post market surveillance
Novo Nordisk A/S

Alex Patterson
Director, Post Market Quality
ResMed

12:15

Networking Luncheon

1:00

CHOOSE BETWEEN TWO 90–MINUTE SESSIONS (7-8)

Session 7: Explore the Impact of Social Media on the Pharmaceutical and Medical Device Industries

I. Guidelines and Enforcement Activities Involving Social Media

II. Social Media Activity in the Pharmaceutical and Medical Device Industries

III. Interactive Exercise

Sharon Perez
Director, Global Medical Safety
Novocure

Session 8: The Balancing Act Between Regulatory Requirements — Public Interest vs Individual Privacy Rights in the EU MDR vs EU GDPR

Meeting the reporting legal requirements of regulations, such as the EU Medical Device Reporting (MDR), and the recently-mandated EU General Data Protection Regulation (GDPR), can be a daunting task. With seemingly clashing requirements, the balancing act that needs to occur within an organization to achieve compliance to both is a delicate one. Has your organization considered the impact of consistently meeting these two regulations simultaneously? This session familiarizes you with both regulations, with a special focus on the critical consideration for implementing them within your organization.

Kari Miller
Vice President, Regulatory and Product Management
Pilgrim Quality Solutions

2:30

Close of Conference